FDA 510(k) Application Details - K955110

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K955110
Device Name	Catheter, Biliary, Diagnostic
Applicant	NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	KELLY BEHRENDT Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1995
Decision Date	11/07/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review